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This randomized phase III trial is studying surgery and axillary lymph node dissection to evaluate if systematic Axillary Lymph Node Excision can be avoided in locoregional treatment for operable breast cancer smaller than 10 mm among menopausal women older than 50
Phase III randomized multicenter equivalence trial evaluating the role of Axillary Lymph Node Excision.
Primary aim is to assess if it is possible to avoid routine Axillary Lymph Node Excision during the initial treatment of breast cancers smaller than 11 mm in women aged 50 and older without compromising survival? The primary endpoint is overall survival: the event considered will be death from any cause.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional surgery WITH Axillary Lymph Node Excision | Experimental | Tumorectomy or mastectomy, WITH Axillary Lymph Node Excision |
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| Conventional surgery WITHOUT Axillary Lymph Node Excision | Active Comparator | Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional surgery WITHOUT Axillary Lymph Node Excision | Procedure | Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Deaths | Five years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Axillary Recurrence | Proportion of participants with axiallary recurrence. Axillary (Regional) recurrence is defined as tumor recurrence in lymph nodes draining the primary tumor site, namely, nodes in the ipsilateral axilla, infraclavicular fossa, supraclavicular fossa and interpectoral area. | Five years after surgery |
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Inclusion criteria:
Women, 50 year or more Menopausal women Breast cancer Macroscopic tumor size of 10 mm or less (measured during operation) No palpable axillary node ( N0)
Exclusion criteria:
Previous cancer history life expectancy < 10 years Metastasis
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| Name | Affiliation | Role |
|---|---|---|
| Antoine AVRIL, MD | Institut Bergonié | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire d'Agen | Agen | 47000 | France | |||
| Centre Régional de Lutte Contre le Cancer d'Anger |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21665421 | Derived | Avril A, Le Bouedec G, Lorimier G, Classe JM, Tunon-de-Lara C, Giard S, MacGrogan G, Debled M, Mathoulin-Pelissier S, Mauriac L; AXIL95 Group. Phase III randomized equivalence trial of early breast cancer treatments with or without axillary clearance in post-menopausal patients results after 5 years of follow-up. Eur J Surg Oncol. 2011 Jul;37(7):563-70. doi: 10.1016/j.ejso.2011.04.008. Epub 2011 Jun 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional Surgery WITH Axillary Lymph Node Excision | Tumorectomy or mastectomy, WITH Axillary Lymph Node Excision Conventional surgery WITH Axillary Lymph Node Excision |
| FG001 | Conventional Surgery WITHOUT Axillary Lymph Node Excision |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Conventional surgery WITH Axillary Lymph Node Excision | Procedure |
|
|
| Angers |
| 49000 |
| France |
| Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest | Bordeaux | 33076 | France |
| Centre Régional de Luttre Contre le Cancer de Clermont Ferrand | Clermont-Ferrand | 63000 | France |
| Centre Régional de Luttre Contre le Cancer de Dijon | Dijon | 21000 | France |
| Centre Régional de Luttre Contre le Cancer de Lille | Lille | 59000 | France |
| Centre Régional de Lutte Contre le Cancer de Lyon | Lyon | 69000 | France |
| Centre Hospitalier Intercommunal de Marmande | Marmande | 47200 | France |
| Centre Régional de Luttre Contre le Cancer de Montpellier | Montpellier | 34000 | France |
| Clinique de la Source | Orléans | 45000 | France |
| Centre Régional de Luttre Contre le Cancer de Nantes | Saint-Herblain | 44800 | France |
| Centre Hospitalier Universitaire de Saint Nazaire | Saint-Nazaire | 44600 | France |
| Centre Régional de Luttre Contre le Cancer de Strasbourg | Strasbourg | 67000 | France |
| Centre Regional de Lutte Contre le Cancer de Toulouse | Toulouse | 31000 | France |
Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision Conventional surgery WITHOUT Axillary Lymph Node Excision: Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Conventional Surgery WITH Axillary Lymph Node Excision | Tumorectomy or mastectomy, WITH Axillary Lymph Node Excision Conventional surgery WITH Axillary Lymph Node Excision |
| BG001 | Conventional Surgery WITHOUT Axillary Lymph Node Excision | Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision Conventional surgery WITHOUT Axillary Lymph Node Excision: Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Deaths | Per protocol population. The following patients were excluded from the PP population :
| Posted | Count of Participants | Participants | Five years after surgery |
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| Secondary | Rate of Axillary Recurrence | Proportion of participants with axiallary recurrence. Axillary (Regional) recurrence is defined as tumor recurrence in lymph nodes draining the primary tumor site, namely, nodes in the ipsilateral axilla, infraclavicular fossa, supraclavicular fossa and interpectoral area. | Posted | Count of Participants | Participants | Five years after surgery |
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10 years
Serious and non-serious adverse events were not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Conventional Surgery WITH Axillary Lymph Node Excision | Tumorectomy or mastectomy, WITH Axillary Lymph Node Excision Conventional surgery WITH Axillary Lymph Node Excision | 10 | 313 | 0 | 0 | 0 | 0 |
| EG001 | Conventional Surgery WITHOUT Axillary Lymph Node Excision | Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision Conventional surgery WITHOUT Axillary Lymph Node Excision: Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision | 24 | 312 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Simone Mathoulin-Palissier, Director of Clinical Trials Unit | Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR | +33 5 56 33 33 33 | s.mathoulin@bordeaux.unicancer.fr |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D008408 | Mastectomy |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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